Finapres Medical Systems Portapres with NiMh battery pack Product Usage: Continuously measure blood pressure, The Portap
FDA device recall Z-2150-2012 · posted 2012-08-06 · Terminated
Recall details
- Recalling firm
- FMS, Finapres Medical Systems BV
- Reason for recall
- Battery may become hot and leak
- Action taken
- Finapres Medical Systems BV sent a Field Safety Notice letter dated July 6, 2012 to notified US accounts of the recall. The letter identified the affected product, description of the problem and actions to be taken. The letter states that the recalling firm recommends not using the affected battery packs. A replacement battery was included in shipment. Customers were requested to return recalled battery. For questions call +31 (0)20 609 0974 or email info@finapres.com.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DXN
- Quantity affected
- 3 units US
- Distribution
- US Nationwide Distribution - including the states of: OH and NY
- Date initiated
- 2012-07-06
- Date posted
- 2012-08-06
- Date terminated
- 2012-09-12
- Location
- Amsterdam, Netherlands
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PORTAPRES AMBULATORY CONTINUOUS NON INVASIVE BLOOD PRESSURE MONITOR,MODEL-2 (K023338) | Fms, Finapres Medical Systems BV | 2003-05-09 |